# K063531: Series 3 Lotus Laparoscopic Ultrasound Surgery System

- Pathway: 510(k) (Traditional)
- Applicant: Sra Developments, Ltd.
- Decided: Feb 22, 2007 after 92 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K900003 (1990). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032424: LOTUS, Sra Developments, Ltd. (2003) Summary page 1.
- K060245: Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. (2006) Summary page 1.
- K971302: Ultracision 5MM Laparosonic Hook Blades, Ultracision HS2 Blade, Ethicon Endo-Surgery, Inc. (1997) Summary page 1.
- K021502: Oscar, Model OE3000, Orthosonics, Ltd. (2002) Summary page 1.

## Most influential descendants
- K151101: Lotus Series 4 Ultrasonic Surgical System & Accessories (2015), 1 descendant of its own
- K221102: LOTUS Series 4 Enhanced Shears, LOTUS Series 5 (2022), 0 descendants of its own

## Indications for use
Series 3 LOTUS shear & hook are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).

Source page: https://510kreport.com/device/K063531
Methodology: https://510kreport.com/methodology